Risperdal Consta and Health Care Utilization in Patients With Schizophrenia

This study is currently recruiting participants.

Verified by Emory University, April 2006

Sponsors and Collaborators:	Emory University Janssen, L.P. - Investigator Initiated Studies Program
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00313391

Purpose

The purpose of this study is to determine if Risperdal Consta will affect the healthcare utilization costs in chronically ill schizophrenic patients with multiple admissions to the psychiatric hospital compared to the previous utilization costs under standard oral treatment of any atypical antipsychotic. We hypothesize that higher Risperdal Consta acquisition costs can be offset by reduction in total medical utilization costs, such as hospitalizations, ER visits, unscheduled outpatient visits or incarcerations due to worsening of psychotic symptoms.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Risperdal Consta	Phase IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:	The Effects of Risperdal Consta on Health Care Utilization Costs in Chronically Ill Schizophrenic Patients

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Primary diagnosis of schizophrenia or schizoaffective disorder
4 or more admissions to psychiatric hospital in past year, OR minimum of 2 hospital admissions and at least 2 incarcerations in the previous year
Medicaid recipient
Patients requiring concomitant non-antipsychotic psychotropic medication (mood stabilizing, antidepressants, anxiolytics)

Exclusion Criteria:

Past or current psychiatric disorder, other than schizophrenia or schizoaffective disorder
Drug or alcohol dependence
Serious, unstable medical illness or any acute medical condition
Pregnant or lactating females
Prior Risperdal Consta treatment
Non-English speaking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313391

Contacts

Contact: Susan Green, MPH

404-321-6111 ext 7343

susan.green@emory.edu

Locations

United States, Georgia
Grady Hospital	Recruiting
Atlanta, Georgia, United States
Contact: Susan Green, MPH 404-321-6111 ext 7343 susan.green@emory.edu
Principal Investigator: Dragana Bugarski-Kirola, MD

Sponsors and Collaborators

Emory University

Janssen, L.P. - Investigator Initiated Studies Program

Investigators

Principal Investigator:

Dragana Bugarski-Kirola, MD

Emory University

More Information

Study ID Numbers:	731-2005
Study First Received:	April 10, 2006
Last Updated:	April 10, 2006
ClinicalTrials.gov Identifier:	NCT00313391
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Risperidone

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009